Crimping devices and methods

Abstract

Devices and methods for crimping a prosthetic heart valve onto a delivery device are described. In some embodiments, valves are crimped over an inflatable balloon and between proximal and distal shoulders mounted on a shaft inside the balloon. Crimping methods can include multiple compression steps with the valve located in different axial positions relative to the crimping jaws at each different step. In some methods, the valve may extend partially outside of the crimping jaws during certain crimping steps, such that the crimping force is only applied to the part of the valve that is inside the jaws. Exemplary crimping devices can include two or more adjacent sets of jaws that close down to different inner diameters, such that different parts of a valve get compressed to different outer diameters at the same time during a single crimping step.

The invention claimed is: 
     
       1. A method of crimping a prosthetic heart valve onto a delivery device, comprising:
 inserting the valve into a crimping device in a radially expanded state such that the valve is positioned within crimping jaws of the crimping device, the crimping jaws having a proximal end and a distal end; 
 positioning an inflatable balloon of the delivery device within the valve, the delivery device comprising a proximal shoulder and a distal shoulder positioned within the balloon; 
 positioning the valve and the delivery device in a first axial position where the valve and at least part of the distal shoulder are within the jaws between the proximal and distal ends of the jaws, and where the entire proximal shoulder of the delivery device is outside of the jaws proximal to the proximal end of the jaws; 
 closing and opening the jaws with the valve and delivery device in the first axial position, such that the valve is at least partially crimped onto the balloon between the proximal shoulder and the distal shoulder; 
 repositioning the valve and delivery device from the first axial position to a second axial position where a first distal portion of the valve and at least part of the distal shoulder are within the jaws, and where a first proximal portion of the valve and the proximal shoulder are outside of the jaws proximal to the proximal end of the jaws; 
 closing and opening the jaws with the valve and delivery device in the second axial position; 
 repositioning the valve and delivery device from the second axial position to a third axial position where a second distal portion of the valve and at least part of the distal shoulder are within the jaws, and where a second proximal portion of the valve and the proximal shoulder are outside of the jaws proximal to the proximal end of the jaws, wherein the second distal portion is axially shorter than the first distal portion, and the second proximal portion is axially longer than the first proximal portion; 
 closing and opening the jaws with the valve and delivery device in the third axial position; 
 repositioning the valve and delivery device from the third axial position to a fourth axial position where the entire valve and at least part of the proximal shoulder of the delivery device are within the jaws, and where the entire distal shoulder of the delivery device is outside of the jaws distal to the distal end of the jaws; and 
 closing and opening the jaws with the valve and delivery device in the fourth position. 
 
     
     
       2. The method of  claim 1 , wherein the first distal portion of the valve includes an outer skirt of the valve. 
     
     
       3. The method of  claim 1 , wherein the second distal portion of the valve includes a distal portion of an outer skirt. 
     
     
       4. The method of  claim 1 , wherein the valve is oriented around the delivery device with a blood inflow end of the valve adjacent the distal shoulder and a blood outflow end of the valve adjacent the proximal shoulder. 
     
     
       5. The method of  claim 1 , wherein closing and opening the jaws with the valve and delivery device in the first axial position comprises radially compressing and releasing the distal shoulder. 
     
     
       6. The method of  claim 1 , wherein closing and opening the jaws with the valve and delivery device in the second axial position comprises radially compressing and releasing the distal shoulder. 
     
     
       7. The method of  claim 1 , wherein closing and opening the jaws with the valve and delivery device in the third axial position comprises radially compressing and releasing the distal shoulder. 
     
     
       8. The method of  claim 1 , wherein closing and opening the jaws with the valve and delivery device in the fourth axial position comprises radially compressing and releasing the proximal shoulder. 
     
     
       9. The method of  claim 1 , wherein closing the jaws with the valve and delivery device in the fourth axial position compresses a proximal portion of the balloon and causes fluid in the balloon to travel distally into a distal portion of the balloon that is outside of the jaws distal to the distal end of the jaws;
 wherein fluid travelling distally into the distal portion of the balloon causes the distal portion of the balloon to partially inflate and expand radially; and 
 wherein the distal portion of the balloon expands radially to a diameter that is greater than a crimped diameter of a distal end of the valve. 
 
     
     
       10. A method of crimping a prosthetic heart valve onto a delivery device, comprising:
 inserting the valve into a crimping device in a radially expanded state such that the valve is positioned within crimping jaws of the crimping device, the crimping jaws having a proximal end and a distal end; 
 positioning an inflatable balloon of the delivery device within the valve, the delivery device comprising a proximal shoulder and a distal shoulder positioned within the balloon; 
 positioning the valve and the delivery device in a first axial position where a first distal portion of the valve and at least part of the distal shoulder are within the jaws between the proximal and distal ends of the jaws, and where a first proximal portion of the valve and the proximal shoulder are outside of the jaws proximal to the proximal end of the jaws; 
 closing and opening the jaws with the valve and delivery device in the first axial position, such that the valve is partially crimped onto the balloon between the proximal shoulder and the distal shoulder; 
 repositioning the valve and delivery device from the first axial position to a second axial position where a second distal portion of the valve and at least part of the distal shoulder are within the jaws, and where a second proximal portion of the valve and the proximal shoulder are outside of the jaws proximal to the proximal end of the jaws, wherein the second distal portion is axially shorter than the first distal portion, and the second proximal portion is axially longer than the first proximal portion; 
 closing and opening the jaws with the valve and delivery device in the second axial position; 
 repositioning the valve and delivery device from the second axial position to a third axial position where a majority of the valve and at least part of the proximal shoulder of the delivery device are within the jaws, and where the distal shoulder of the delivery device is outside of the jaws distal to the distal end of the jaws; and 
 closing and opening the jaws with the valve and delivery device in the third position; 
 wherein closing the jaws with the valve and delivery device in the third axial position compresses a proximal portion of the balloon and causes fluid in the balloon to travel distally into a distal portion of the balloon that is outside of the jaws distal to the distal end of the jaws, wherein fluid travelling distally into the distal portion of the balloon causes the distal portion of the balloon to inflate and expand radially. 
 
     
     
       11. The method of  claim 10 , wherein fluid travelling distally into the distal portion of the balloon causes the distal portion of the balloon to expand radially to a diameter that is greater than a crimped diameter of a distal end of the valve. 
     
     
       12. The method of  claim 10 , wherein the first distal portion of the valve includes an outer skirt of the valve. 
     
     
       13. The method of  claim 10 , wherein the second distal portion of the valve includes a distal portion of an outer skirt. 
     
     
       14. The method of  claim 10 , wherein the valve is oriented around the delivery device with a blood inflow end of the valve adjacent the distal shoulder and a blood outflow end of the valve adjacent the proximal shoulder. 
     
     
       15. The method of  claim 10 , wherein closing and opening the jaws with the valve and delivery device in the first axial position comprises radially compressing and releasing the distal shoulder. 
     
     
       16. The method of  claim 10 , wherein closing and opening the jaws with the valve and delivery device in the second axial position comprises radially compressing and releasing the distal shoulder. 
     
     
       17. The method of  claim 10 , wherein closing and opening the jaws with the valve and delivery device in the third axial position comprises radially compressing and releasing the proximal shoulder.